Zidebactam

Mumbai: Wockhardt is working on ambitious plans for Zaynich , a combination of zidebactam and cefepime that was found to be effective during clinical trials to fight superbugs or bacterial infections that show resistance to a range of existing antibiotic treatments. The drug maker has hired merchant bankers to identify possible out-licensing deals for the novel product, chairman Habil Khorakiwala told ET in an exclusive interview. Wockhardt in March sought regulatory approval for Zaynich in India and expects its commercial launch in the first half of ’26. In the US, it plans to file for regulatory clearance in August.“We will get into the US market by the end of FY26 or latest by the second half of 2026 and Europe will be a year later,” Khorakiwala said. Zaynich is seen as a game-changing drug against drug-resistant gram-negative pathogens. These pathogens are difficult to kill. Zaynich is estimated to have a market opportunity of about $9 billion. Around a million people die due to multidrug resistance in India every year, while worldwide, the number is 5 million, Khorakiwala said. Currently there are very few effective treatments available for these infections. Mumbai-based Wockhardt completed the Phase-3 clinical trials for Zaynich earlier this year. In January it announced that the drug demonstrated more than 97% clinical efficacy in treating serious infections of bacteria resistant to carbapenem antibiotics, which are often used as a last resort to treat severe infections. The company is prepared to go solo to market Zaynich in India, the US and other markets if the licensing proposals do not meet its expectations on valuation, Khorakiwala said without revealing the valuation he is looking for. “We will evaluate how to go about and take an appropriate call, so we are keeping two options fully alive,” Khorakiwala said. “One option is licensing out, the other is in some markets like in India we are doing ourselves,” he said. “The US is another market where we are thinking of the possibility (of marketing on its own); you don’t need too much marketing cost and you have talent available.” Wockhardt also plans to fully outsource manufacturing for the Western markets to eliminate issues related to the US Food and Drug Administration, and channel its focus on the clinical and research part. “For manufacturing, plenty of options are available in Europe and the US, so I am not getting into FDA-related manufacturing problems,” said Khorakiwala. “Zaynich — we are manufacturing everything in Europe.” It will adopt the same strategy to outsource most of the manufacturing for all its other new products. The company had in the past faced some issues with the US FDA over alleged violations of good manufacturing practices. “That (FDA-elated manufacturing problems) was our weakness, and I am eliminating that completely from my western markets to only focus on the clinical and research part,” he said. COMPANY TURNAROUND Wockhardt has seen a remarkable turnaround in its stock price in the past year and a half with renewed confidence from investors, with developments on Zaynich being among the key drivers. Its stock price more than doubled in the last 12 months and increased over three-and-a-half times since January 2024. The shares closed at `1,713.20, up 4.5%, on BSE Monday. “We have revisited what are the strengths and what are the opportunities — one obviously is our new drug discovery — in India and worldwide,” said Khorakiwala. He also stressed on the company’s focus on biologics as another key growth driver. “Within biologics we will stay in insulin and GLP1; we are not going to touch the rest of the biologics like monoclonal antibodies and others. Because we feel it is important to be focused,” he said. Wockhardt does not see itself as a generic company, he said. “In fact, in the US we are exiting generics … we will be focused on the biological area and NCE (new chemical entities) and strictly on antibiotics,” he said. The chairman said his research pipeline has a range of antibiotics under development, including early-stage work on an oral version of Zaynich. PRICING STRATEGY Khorakiwala said the treatment cost with most new products including antimicrobials launched in the last 10 years in the US has been in the range of $10,000-15,000 per treatment. Zaynich will also hover in that range in the US but in India, the price will be significantly lower, he said. By Rica Bhattacharyya ,

Dubai: Habib Khorakiwala , Chairman of Indian pharmaceutical company Wockhardt , on Friday said 'Zaynich,' its medicine for multi-drug resistant infections , is set to get the US Food and Drug Administration ( USFDA ) approval next year. Zaynich is a novel antibiotic developed to target multi-drug-resistant Gram-negative infections. "We started our research programme 25 years ago. And today we have six drugs for multi-drug resistance," the Chairman of the Indian pharmaceutical company told on the sidelines of the ongoing 'Global Justice- Love and Peace Summit' in Dubai. "We are the most successful research company, in the world, in antibiotic research today.... I think our contribution is not only making the drug affordable in India but saving many, many lives, and we will be marketing these products in the USA and Europe, and we hope that our main drug 'Zaynich' will get USFDA approval sometime next year," Habib Khorakiwala said. Reportedly, Wockhardt discovered a 100 per cent clinical cure rate among 30 critically ill patients treated with Zaynich -- a combination of Zidebactam and Cefepime -- for life-threatening, drug-resistant infections. Habib Khorakiwala, talking to ANI on Friday, also indicated that the US administration's imposition of tariffs on pharmaceutical products would be counterproductive for Americans. The US now imposes a 10 per cent baseline tariff on all imported goods. The remaining reciprocal tariffs imposed by the US on dozens of partner countries have been paused for 90 days, except for China. Faced with reciprocal tariffs, as many as 75 partner countries are actively negotiating a trade deal with the US. Wockhardt Chairman told ANI that India supplies 40 per cent of prescription drugs to the United States. "And over the years, we (India) made so much contribution in making products available at a reasonable price (in the US)," said Khorakiwala. "The whole approach would be counterproductive for the American people, mainly because when it is not easier to switch, for medicine, because the approval process by USFDA takes several years," the pharma company boss said. Against that backdrop, Habib Khorakiwala said he believes that whatever tariff comes on pharma, if at all, a significant part of it will be transferred to the American healthcare system. On Tuesday night (local time), US President Donald Trump announced that tariffs on the pharma sector were coming soon. The sector has so far been exempted from the tariffs. Further, Khorakiwala said the cost of putting a pharma facility in the US would be significantly higher. "And the cost advantage which is available (at present), would be completely reduced. India's success over the years, last 20-25 years in the US is mainly because we could meet the US requirement with the quality they want and at the price which is globally competitive, and that is our Indian strength," Khorakiwala added. On top of the manufacturing cost, Khorakiwala asserted that the research cost in the US is in multiples to that in India. "There are two aspects of costs. One is the manufacturing cost. It is about 3 to 4 times more. Second, more important in our industry is the research cost, and that is 10 to 20 times more," he argued.